{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65108",
      "recalling_firm": "American Optisurgical Inc",
      "address_1": "26902 Vista Ter",
      "address_2": "N/A",
      "postal_code": "92630-8123",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.",
      "recall_number": "Z-1518-2013",
      "product_description": "TX1 Tissue Removal System disposable handpieces.    Product Usage:  The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.",
      "product_quantity": "1,436 units",
      "reason_for_recall": "American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.",
      "recall_initiation_date": "20130430",
      "center_classification_date": "20130607",
      "termination_date": "20140324",
      "report_date": "20130619",
      "code_info": "Lot Numbers:  00312-07,  00713-06,  00912-01,  01813-02,  02413-04,  03113-02,  04213-01,  05113-01,  05113-02,  05512-03,  05713-03,  06313-05,  06512-08,  06513-02,  07213-04,  07912-06,  08212-07,  09412-03,  11412-06,  11612-05,  12912-04,  14512-07,  15312-03,  16412-07,  17412-01,  18712-06,  19812-13,  20212-03,  21412-03,  22212-03,  23412-06,  24112-06,  24212-04,  24912-13,  25712-01,  26912-01,  27712-05,  28512-03,  28912-03,  29612-01,  30512-02,  31112-05,  32112-03,  33112-01,  34712-05,  36612-01"
    }
  ]
}